EZ Steer BD7TCFF4L
GUDID 10846835002553
BIOSENSE WEBSTER INC.
Cardiac radio-frequency ablation system catheter| Primary Device ID | 10846835002553 |
| NIH Device Record Key | 814d132f-15eb-4fd6-9fe2-ce36d3c53ebf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZ Steer |
| Version Model Number | BD7TCFF4L |
| Catalog Number | BD7TCFF4L |
| Company DUNS | 020163218 |
| Company Name | BIOSENSE WEBSTER INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry | Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is opened |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10846835002553 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P950005
FDA Product Code
| LPB | Cardiac ablation percutaneous catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-06-28 |
| Device Publish Date | 2014-09-10 |
On-Brand Devices [EZ Steer]
| 10846835002751 | BD7TJJ4L |
| 10846835002720 | BD7TFJ4L |
| 10846835002706 | BD7TFF4L |
| 10846835002676 | BD7TDF4L |
| 10846835002652 | BD7TDD4L |
| 10846835002621 | BD7TCJJ4L |
| 10846835002584 | BD7TCFJ4L |
| 10846835002553 | BD7TCFF4L |
| 10846835002515 | BD7TCDF4L |
| 10846835002485 | BD7TCDD4L |
Trademark Results [EZ Steer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EZ STEER 88558534 not registered Live/Pending |
Super ATV, LLC 2019-08-01 |
 EZ STEER 77730584 3838854 Dead/Cancelled |
THE AMES COMPANIES, INC. 2009-05-06 |
 EZ STEER 76665927 3543965 Live/Registered |
BIOSENSE WEBSTER, INC. 2006-09-11 |
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